Effects of Sodium-Glucose Co-transporter 2 Inhibitors on Inflammation (NCT06812429) | Clinical Trial Compass
CompletedEarly Phase 1
Effects of Sodium-Glucose Co-transporter 2 Inhibitors on Inflammation
United States6 participantsStarted 2024-05-08
Plain-language summary
The research aims to understand how a specific type of medication called Sodium-glucose co-transporter 2 (SGLT2) inhibitors affect cardiorenal inflammation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: ≥18
* Patient has no prior history or use of Sodium-Glucose Co-transporter 2 Inhibitors.
* Women who are surgically sterilized, amenorrheic for a year, on long-term contraceptives like intrauterine devices and implantable and injectable contraceptives.
* Willing and able to complete the outcome assessments.
Exclusion Criteria:
* History of cardiac diseases (Heart Failure, NSTEMI/STEMI, cardiomyopathies, myocarditis).
* Diagnosis of Type I Diabetes Mellitus.
* Symptomatic hypotension (symptoms of hypotension + Systolic blood pressure \< 90).
* Estimated glomerular filtration rate \<25 mL/minute/1.73 m2, with renal function test done within a year from the study enrollment date.
* Alcohol use disorder as defined by the NIAAA or use of controlled substances or smoking cigarettes.
* History of dapagliflozin or other Sodium-Glucose Co-transporter 2 Inhibitor sensitivity.
* Other concomitant disease or condition that the investigator deems unsuitable for the study, including psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
* Women who are pregnant or intend to become pregnant
What they're measuring
1
Change from baseline in the markers of Inflammation at three days
Timeframe: From enrollment to the end of treatment at 3 days.